Entral Feeding in Acute Severe Pancreatitis

NCT ID: NCT04406506

Last Updated: 2020-05-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-10
• Study Completion Date: 2020-04-10

Brief Summary

• A total of 60 patients admitted to King Abdulaziz Specialists Hospital between June 2018 and April 2020 with both a clinical and biochemical presentation of acute pancreatitis with the following inclusion criteria: Abdominal pain > 6 on the visual analogue scale without given analgesia , abdominal distension and tenderness with serum amylase and serum lipase at least 3 times the upper limit of the reference range (considering normal lipase level from 0-160 U/L, and normal amylase level from 0-100 U/L) with confirmed abdominal computerized axial tomography of grade D and E on Ranson and colleagues criteria(28) of inflamed pancreatic picture.

Detailed Description

• The study was conducted on monitoring of four pillar for 13 days (data collected one day before feeding and every three days for 12 days). the first pillar comparing the effect of the two enteral feeding methods on the clinical condition of the acute severe pancreatitis and this monitored clinically and laboratory by fixed parameters, clinically, by abdominal pain which assessed by visual analogue scale (VAS). and laboratory, by both markers of severity of pancreatic acini destruction which assessed by serum amylase, lipase and Markers of severity of interstitial pancreatic tissue destruction which assessed by the level of Lactate Dehydrogenase level (LDH), Aspartate aminotransferase (AST), C-reactive protein, prostacyclin and interleukin 8. The second pillar include effect of the two enteral feeding methods on the patient's tolerance and these monitored in our study by both post-feeding vomiting and post feeding attacks of osmotic diarrhea and also abdominal pain. Third pillar include effect of the two enteral feeding methods on the patient's general condition and these monitored by follows the APACHE II Score, hemodynamics of the patients in both groups (Mean arterial blood pressure and pulse) and arterial oxygen saturation (Spo2). Fourth pillar include effect of the two enteral feeding methods on achieving satisfactory nutrition parameters of the patients and both albumin level, radium blood sugar and electrolytes (sodium and potassium level) used as indicator for this.
• All parameters observed one day before starting feeding and every 3 days for 12 days (duration of the study).

Conditions

Postoperative Nausea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A

Group A received nasogastric feeding (NG), insure through ngt pump

nasogastric

Intervention Type: DEVICE

• The insertion of NG tubes were performed by the ICU physician and the position was checked by auscultation of gas from 50 ml syringe by injecting 20 ml of air in the NG and by X-ray abdomen to be sure from the site of NG tube

(erythromycin 250 mg IV bolus)

Intervention Type: DRUG

prokinetic (erythromycin 250 mg IV bolus) given to assist the passage of the tube through the pylorus

Group B

• receive feeding throughThe nasojejunal tube is silicone or polyurethane tube with an inner stylet that is positioned (under fluoroscopic guidance) beyond the ligament of Treitz.
• Patients were placed in right lateral position

nasojejunal

Intervention Type: DEVICE

• The nasojejunal tube is silicone or polyurethane tube with an inner stylet that is positioned (under fluoroscopic guidance) beyond the ligament of Treitz.
• Patients were placed in right lateral position

(erythromycin 250 mg IV bolus)

Intervention Type: DRUG

prokinetic (erythromycin 250 mg IV bolus) given to assist the passage of the tube through the pylorus

Interventions

nasogastric

• The insertion of NG tubes were performed by the ICU physician and the position was checked by auscultation of gas from 50 ml syringe by injecting 20 ml of air in the NG and by X-ray abdomen to be sure from the site of NG tube

Intervention Type: DEVICE

nasojejunal

• The nasojejunal tube is silicone or polyurethane tube with an inner stylet that is positioned (under fluoroscopic guidance) beyond the ligament of Treitz.
• Patients were placed in right lateral position

Intervention Type: DEVICE

(erythromycin 250 mg IV bolus)

prokinetic (erythromycin 250 mg IV bolus) given to assist the passage of the tube through the pylorus

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• acute pancreatitis

Exclusion Criteria

• systemic disease as hypertension or diabetes

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Abdul Aziz Specialist Hospital

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

King abd el Aziz specialist hospital

Ta'if, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

ICU-28-20

Identifier Type: -

Identifier Source: org_study_id